fiercepharmaApril 04, 2019
Tag: BMS , Opdivo , lung cancer
After a hard blow to its hopes in previously untreated lung cancer, Bristol-Myers Squibb is clinging to its share of the second-line market. And it’s hoping new long-term data can help it hang on.
Tuesday at the American Association for Cancer Research, the New Jersey drugmaker shared results from a pooled analysis of two phase 3 studies of patients with advanced non-small cell lung cancer who hadn’t received previous treatment. And they showed that at the four-year mark, 14% of all Opdivo-treated patients were still alive, compared with just 5% of those who had received chemo instead.
What’s more, 58% of those who had responded to Opdivo at the six-month mark, either partially or completely, were still alive four years later, versus just 12% of chemo patients.
"We always said that one of the hallmarks of immuno-oncology is durability of response and that durability is important. Here we can now see a clear demonstration of how response status … impacts overall survival," Sabine Maier, M.D., Bristol’s development lead for thoracic cancers, said.
In Bristol’s presentation, you could "see how flat" the Opdivo curve was, Maiers added. "Those patients tend to survive very long" versus the chemo arm, in which "you see a constant decline over time as patients lose their response and keep dying."
The way she sees it, the analysis has "direct implications" for patients who receive Opdivo in the second-line setting—and for doctors who prescribe it. The results should help physicians talk to their patients about treatment decisions and reassure patients about their long-term outcomes.
"I think it’s very important for them to understand that once you hit the six-month landmark, what your survival expectations actually are in that setting," she said.
Bristol-Myers Squibb last year surprised analysts by hanging onto a good portion of Opdivo’s second-line share despite stellar survival data that boosted uptake of Merck archrival Keytruda in new patients—and shrunk Bristol’s patient pool accordingly.
Investors, though, have worried the company won’t be able to keep it up, and that Opdivo will soon be faltering in the other indication fueling its success—in kidney cancer—thanks to Keytruda competition, too.
Meanwhile, though, BMS’ decision to yank its application for an Opdivo-Yervoy combo in front-line lung cancer has confirmed their worst fears: that Opdivo is still a long ways away from challenging Keytruda in immuno-oncology’s most lucrative market.
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